Basiliximab

SOURCE: UK SPC (eMC) for Simulect 10 mg powder for solution for injection or infusion, section 4.2 (https://www.medicines.org.uk/emc/product/102333/smpc). Should be prescribed only by physicians experienced in the use of immunosuppressive therapy following organ transplantation, and administered under qualified medical supervision. Must not be administered unless it is absolutely certain that the patient will receive the graft and concomitant immunosuppression. Used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression, and may be used in a triple regimen additionally including azathioprine or mycophenolate mofetil. WITHHOLD the second dose in the event of a severe hypersensitivity reaction or post-operative complications such as graft loss. ELDERLY (65 years and over): limited data, but no evidence that elderly patients require a different dosage from younger adults. PAEDIATRIC (children and adolescents 1-17 years; weight-banded fixed dosing, not a per-kg dose, hence paedDose is null): patients weighing less than 35 kg - recommended total dose 20 mg, given as two doses of 10 mg each; patients weighing 35 kg or more - the adult dose, i.e. a total dose of 40 mg given as two doses of 20 mg each. In both bands, the first dose is given within 2 hours prior to transplantation surgery and the second dose 4 days after transplantation, with the second dose withheld in the event of severe hypersensitivity or post-operative complications such as graft loss. Verify paediatric use against a children's formulary. US labelling (openFDA, Simulect, Novartis, 2025-12-12) states the same adult and paediatric regimens and adds that the product is for central or peripheral intravenous administration only, that the reconstituted solution may be diluted to 25 mL (10 mg vial) or 50 mL (20 mg vial) with 0.9% sodium chloride or 5% dextrose for infusion over 20 to 30 minutes, and that bolus administration may be associated with nausea, vomiting and local reactions including pain.